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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K934570
Device Name SPECTACLE FRAMES
Applicant
Chaser Optical Corp.
Ohbe Bldg., 2nd Floor 3-14
2-Chome Ohbe
Kawanishi-Shi, Hyogo-Ken,  JP 666-0014
Applicant Contact CHIHARU ISHIBE
Correspondent
Chaser Optical Corp.
Ohbe Bldg., 2nd Floor 3-14
2-Chome Ohbe
Kawanishi-Shi, Hyogo-Ken,  JP 666-0014
Correspondent Contact CHIHARU ISHIBE
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received09/16/1993
Decision Date 03/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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